Chapter 4 Prerequisite Programs

Food Code Interventions HACCP Prerequisites SOPs Control Contamination of Food Control Microbiological Growth Maintain Equipment

FOOD CODE INTERVENTIONS

The provisions of the Food Code provide a foundation on which to develop a food safety system based upon the principles of HACCP. Major interventions in the Food Code are demonstration of knowledge by the person-in-charge, employee health, no bare hand contact with ready-to-eat food, time and temperature control, and the use of a consumer advisory regarding the consumption of raw or undercooked animal foods. These interventions need to be addressed within the overall food safety program which may entail inclusion in SOPs. Refer to Chapters 2 and 3 of the Food Code for specific controls that need to be in place.

HACCP PREREQUISITES

Many provisions of the Food Code address the design of food establishments and equipment as well as acceptable operational practices. Adherence to design criteria and development of SOPs affect the food preparation environment. Both are considered prerequisite to the development of food safety systems based upon the HACCP principles. SOPs specify practices to address general hygiene and measures to prevent food from becoming contaminated due to various aspects of the food environment. When SOPs are in place, HACCP can be more effective because it can concentrate on the hazards associated with the food and its preparation and not on the food preparation facility.

STANDARD OPERATING PROCEDURES (SOPs)

SOPs specific to your operation describe the activities necessary to complete tasks that accomplish compliance with the Food Code, are documented as a written reference, and are used to train the staff who are responsible for the tasks.

Three purposes for establishing SOPs for your operation are to protect your products from contamination from microbial, chemical, and physical hazards; to control microbial growth that can result from temperature abuse; and to ensure procedures are in place for maintaining equipment.

SOP procedures ensure that:

• product is purchased from approved suppliers/sources,

• the water in contact with food and food-contact surfaces and used in the manufacture of ice is potable,

• food-contact surfaces, including utensils are cleaned, saniti zed, and maintained in good condition,

• uncleaned and nonsanitized surfaces of equipment and utensils do not contact raw or cooked ready-to-eat food,

• raw animal foods do not contaminate raw or cooked ready-to-eat food,

• toilet facilities are accessible and maintained,

• handwashing facilities are located in food preparation, food dispensing, warewashing areas, and immediately adjacent to toilet rooms and are equipped with hand cleaning preparations and single-service towels or acceptable hand drying devices,

• an effective pest control system is in place,

• toxic compounds are properly labeled, stored, and safely used ,

• contaminants such as condensate, lubricants, pesticides, cleaning compounds, sanitizing agents, and additional toxic materials do not contact food, food packaging material, and food-contact surfaces, and

• food, food packaging materials, and food-contact surfaces do not come in contact with, and are not contaminated by physical hazards such as broken glass from light fixtures, jewelry, etc.

SOPs to Control Contamination of Food

Procedures must be in place to ensure that proper personnel health and hygienic practices are implemented including:

• restricting or excluding workers with certain symptoms such as, vomiting or diarrhea (see Food Code Chapter 2),

• practicing effective handwashing,

• restricting eating, smoking, and drinking in food preparation areas,

• using hair restraints,

• wearing clean clothing, and

• restricting the wearing of jewelry.

SOPs to Control Microbial Growth

These procedures ensure that all potentially hazardous food is received and stored at a refrigerated temperature of 41°F or below. Note that the Food Code makes some allowances for specific foods that may be received at higher temperatures - refer to Chapter 3, Specifications for Receiving.

SOPs to Maintain Equipment

These procedures ensure that:

• temperature measuring devices (e.g., thermometer or temperature recording device) are calibrated regularly,

• cooking and hot holding equipment (grills, ovens, steam tables, conveyor cookers, etc.) are routinely checked, calibrated if necessary and are operating to ensure correct product temperature,

• cooling equipment (refrigerators, rapid chill units, freezers, salad bars, etc.) are routinely checked, calibrated if necessary and are operating to ensure correct product temperature, and

• warewashing equipment is operating according to manufacturer's specifications.

NOTICE: This is a Draft document to guide operators in voluntarily applying HACCP principles in food establishments in the retail segment. It will be trial tested in a structured FDA pilot. The pilot, Notice of which will appear in the Federal Register, is an open process and as experience is gained from the various phases of that pilot, this Guide will be modified. The Agency recognizes that this document has areas that need to be further clarified and developed with broader input and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. The Guide will continue to evolve and improve. It is anticipated that the field application of this guidance document will identify additional processes, special food considerations, or other facets of a HACCP program that need to be addressed. It is also expected, as reflected in the Annex, that the listing of commodity-specific hazards will be expanded to further ass developing their HACCP systems. The Agency fully recognizes the diversity of "retail food establishments" and their varying in-house resources to implement HACCP. That recognition is combined with an understanding that the success of such implementation is dependent upon identifying realistic and useful ways of making it happen that are customized to the operation. FDA is open to record keeping applications that minimize the burden of instituting a HACCP system while providing the added consumer protection. FDA is most interested in receiving comments from parties who may review or use this Guide either within the pilot program or outside of that process. Of particular interest to the Agency are alternative ways of controlling hazards, input regarding special food considerations as described in Annex 2, and specific comments with respect to providing additional practical HACCP guidance for the retail industry. To submit comments, please photocopy the pages of concern, mark them up with your suggested changes, and forward them to: Dr. John E. Kvenberg HACCP Policy Strategic Manager (HFS-10) Office of Policy, Planning and Strategic Initiatives Food and Drug Administration 200 C Street, S. W. Washington, DC 20204